Regulatory and Risk Manager

We are currently working with a ground breaking medical device manufacturing company, who are in a state of growth and therefore looking to recruit a Regulatory and Risk Manager to their team based near Warwick. Your purpose in this role will be to develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required. You will be responsible to the Director of Quality and Regulatory Affairs.

Essential Candidate Experience:

?? Experience as a Regulatory Manager with ideally some team leading or management experience.

?? 510K and FDA submission experience

Key Responsibilities

To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance.

To deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans.

To define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways.

To provide advice on possible approaches to de-risking and accelerating project completion.

To provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements.

To provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development lifecycle.

To provide managerial leadership for RA team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets.